Roche ACCU-CHEK Performa blood glucose test strips, Roche Diagnostics, Indianapolis, IN. Test strips for quantitative bl
FDA device recall Z-2005-2009 · posted 2009-09-16 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- There may be a significant negative bias when testing neonate samples.
- Action taken
- Roche Diagnostics notified consignees in the affected countries of the problem by "Urgent Field Safety Notice" dated June 10, 2009 and instructed to cease using the Accu-Chek Performa and Accu-Chek Inform II systems on neonates, except for systems using test strips with advanced chemistry. For questions and additional information, contact your local Roche Diagnostics sales affiliate or sales representative.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 1,518 of total products
- Distribution
- International Distribution -- Argentina, Australia, Brazil, Chili, China, Colombia, Ecuador, France, Germany, Great Britain, Hong Kong, India, Korea, Malaysia, Mexico, New Zealand, Pakistan, Panama, P
- Date initiated
- 2009-06-10
- Date posted
- 2009-09-16
- Date terminated
- 2010-10-29
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCU-CHEK PERFORMA SYSTEM (K070585) | Roche Diagnostics Corp. | 2007-05-25 |